Breast Cancer, Breast Diseases, Breast Neoplasms
Conditions
Keywords
Mastectomy and axillary dissection surgery, Postoperative pain management, Erector Spinae Plane Block
Brief summary
Postoperative pain is an important issue in female patients underwent breast surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a relatively novel interfascial block that was defined by Forero et al. It has been reported that ESPB provides effective analgesia management for several breast surgeries.
Detailed description
Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. The US-guided erector spina plane block (ESPB) provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. ESPB contains a local anesthetic injection into the deep fascia of erector spinae. Visualization of sonoanatomy is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, it has been reported that ESP block provides effective analgesia after several surgeries such as open heart surgery, breast surgery, thoracoscopic and abdominal operations. The aim of this study is to compare the efficacy of the different volumes of US-guided ESPB for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption, and the secondary aim is to evaluate pain scores (VAS), and adverse effects related with opioids (allergic reaction, nausea, vomiting).
Interventions
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant and the anesthesiologist who will perform postoperative pain evaluation and opioid consumption will not know the group
Intervention model description
There are two models for this study. The first group is 30 ml volume ESPB group. The second one is 20 ml volume ESPB group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) classification I-II * Scheduled for mastectomy and axillary dissection surgery under general anesthesia
Exclusion criteria
* anticoagulant treatment, * known local anesthetic allergy, * infected skin around the block site, * pregnancy or breast-feeding, * back abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative opioid consumption (need and demand as microgram) | Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours. | The primary aim is to compare postoperative opioid (fentanyl) consumption on patient controlled analgesia device. The parameters on PCA devices such as delivery and demand will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores (Visual analogue scores-VAS) | Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours | Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded |
Countries
Turkey (Türkiye)
Outcome results
None listed